Senior Supplier Quality Engineer
Company: InfraredX, Inc.
Location: Bedford
Posted on: May 18, 2024
Job Description:
Responsible for ensuring that Infraredx's suppliers provide high
quality materials and/or services that conform to the needs of
Infraredx product quality and regulatory requirements. Key team
member providing expertise on the capability of our suppliers, in
establishing and maintaining the technical activities of our
suppliers, and ensuring they meet business needs. Key
Responsibilities:
- Utilize risk-based approach in the classification and
management of Infraredx suppliers.
- Provide daily support for supplier issues arising at incoming
inspection or on manufacturing floor.
- Interface with suppliers to obtain quality data and resolve
quality issues. Resolution of quality issues to include
responsibility of supplier non-conformances, corrective action
requests, and CAPA.
- Participate in qualification of new suppliers, including
supplier selection and approval.
- Responsible for coordination of initial component quality
requirements including first article inspection, process
qualification, and assisting in supplier validation activities such
as writing/approving protocols.
- Responsible for maintaining the Approved Supplier List.
- Provide insight regarding supplier capabilities for new and
existing products, in collaboration with manufacturing,
engineering, R&D, and marketing.
- Conducts external supplier audits, as assigned, to ensure QMS
compliance.
- Maintains supplier quality records in accordance with FDA/GMP
and EU MDR requirements.
- Coordinate review of supplier change requests with
cross-functional team, including evaluation of change,
implementation planning, and approval.
- Assist with supplier quarterly evaluation activities (Supplier
Performance Scorecard).
- Ability to identify under-performing suppliers and work to
improve them or reduce defect occurrence rates, initiating transfer
activities to alternative suppliers when necessary.
- Consolidation of supply base through identification of
redundant capabilities and initiating/supporting manufacturing or
service transfers as needed.
- Initiate and drive process/yield improvement projects where
possible.
- Develop and support requirements and activities for
"dock-to-stock" program.
- Acts as a team member in supporting quality disciplines,
decisions, and practices.Requirements:
- Bachelor of Science degree in a technical discipline.
- 5-7+ years of quality engineering in life sciences industry,
supplier quality experience strongly preferred.
- Proven track record with supplier selection, approval, and
management.
- Strong written/verbal communication skills and demonstrated use
of quality tools/methodologies.
- Working knowledge of FDA/QSR, ISO, EU MDR standards, process
validation, product design control, CAPA, and FMEA
methodologies.
- Proficient with Microsoft Office applications, and willingness
to learn Infraredx ERP and PLM systems.
- Certified Internal Auditor and/or experience performing
Internal Audits strongly preferred.
- Current ASQ and/or six sigma certifications preferred.
PI0fbe53d2c68f-31181-34482093
Keywords: InfraredX, Inc., Arlington , Senior Supplier Quality Engineer, Engineering , Bedford, Massachusetts
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